Protara Therapeutics
Protara Therapeutics is a biopharmaceutical company based in New York, focusing on developing treatments for non-muscle invasive bladder cancer, lymphatic malformations, and choline deficiency in patients on parenteral nutrition.
Company Overview
Protara Therapeutics is a biotechnology company based in New York, located at 345 Park Avenue South, 3rd Floor, New York, NY 10010. The company focuses on developing treatments for cancer and rare diseases. Protara Therapeutics is notable for its investigational therapies, including TARA-002 and IV Choline Chloride, which aim to provide innovative solutions for conditions with limited treatment options.
Lead Investigational Therapy: TARA-002
TARA-002 is Protara Therapeutics' lead investigational cell therapy. It is based on OK-432, a broad immunopotentiator already approved in Japan and Taiwan for multiple oncologic indications and lymphatic malformations (LMs). In the U.S., TARA-002 is under evaluation for treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations. TARA-002 has also received Rare Pediatric Disease Designation and Orphan Drug Designations from the U.S. FDA.
Investigational Therapy: IV Choline Chloride
IV Choline Chloride is another key investigational therapy by Protara Therapeutics. It is a phospholipid substrate replacement therapy designed for patients on parenteral nutrition (PN), many of whom suffer choline deficiency and liver damage. IV Choline Chloride is poised to become the first FDA-approved IV choline formulation for these patients. It has been granted Orphan Drug Designation for the prevention of choline deficiency in PN patients, and the company has aligned with the FDA on its registrational path forward.
Financial and Regulatory Milestones
In April 2024, Protara Therapeutics announced an oversubscribed $45 million private placement financing. Additionally, the company reported alignment with the FDA on the registrational path forward for IV Choline Chloride for PN patients and positive three-month data from the TARA-002 clinical program in NMIBC. These milestones demonstrate regulatory progress and financial support for the company's key investigational therapies.
Bladder Cancer and Lymphatic Malformations
Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) constituting approximately 80% of diagnoses. Roughly 65,000 patients are diagnosed with NMIBC annually in the U.S. There are currently no approved therapies for lymphatic malformations (LMs), which underscores the potential impact of TARA-002. Protara Therapeutics is working to address these unmet medical needs with their innovative treatments.